PV Writing and Consulting Services, LLC

Your Trusted Partner in the Pharmaceutical Industry

With over 20 years of combined experience in clinical trial quality and pharmacovigilance (PV), we specialize in authoring aggregate safety reports, PV Agreements, Safety Data Exchange Agreements, clinical trial document quality review, SOP development, and more.

Trust us for preparing your aggregate safety reports on time and with quality.

If you prefer to prepare aggregate safety reports yourself, we also offer ICH compliant report templates that include customizable proposed positive and negative responses.

Explore Services

Aggregate Safety Report Authoring and ICH Compliant Template Development

We excel in creating comprehensive aggregate safety reports, such as DSUR, PBRER, RMP and REMS Assessment Report, ensuring regulatory compliance and accuracy in every document. We are also experienced in creating PV Agreements and Safety Data Exchange Agreements.

For clients preferring to keep authoring responsibilities in-house, we also offer ICH compliant aggregate safety report templates, which contain customizable positive/ negative responses to facilitate the authoring process, and document preparation timeline templates (30, 60 or 90 day).

Report Project Management, Document QC and SOP Development

Our team specializes in efficient report project management, meticulous document QC, and SOP development to streamline processes for our clients.

Consulting Services

Benefit from our expert pharmacovigilance consulting for guidance on aggregate report requirements, informed consent form risk language, and more.

About Us

Leading the Way in Pharmacovigilance Writing and Consultation

At Pharmacovigilance Writing and Consulting Services, LLC, our writing team has a broad range of expertise in authoring aggregate safety reports, Pharmacovigilance Agreements, Safety Data Exchange Agreements, creating SOPs, providing detailed project timelines, performing the quality review of clinical trial documents, and much more.

We have a deep-rooted history of excellence in providing quality consultation for all therapeutic areas and phases of clinical trials, and providing consultation on pharmacovigilance activities throughout a product's lifecycle.